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NCT Number: NCT07262320

Epidemiology and Processes of Care for Renal Replacement Therapy in Acute Kidney Injury in Latin America

This is an international, multicenter, observational study aimed at investigating acute kidney injury requiring renal replacement therapy (AKI-RRT) in Latin American countries. The main questions this study aims to answer are:

* What is the epidemiology, outcomes, and processes of care for patients with AKI-RRT in Latin America? * How do outcomes differ across different countries in Latin America? * What factors (demographics, clinical, socioeconomic) influence outcomes in patients with AKI-RRT in Latin America?

The main aims of this study are to:

* Establish a comprehensive database containing clinical, laboratory, treatment, process, and outcome data of patients with AKI-RRT in Latin America * Describe current epidemiology of AKI-RRT in Latin America * Compare processes of care and outcomes across different countries in Latin America * Provide data resources to facilitate and promote clinical research in AKI-RRT

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Obrero No 2, Cochabamba, Bolivia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient (≥18) admitted to the ICU
  • First ICU admission during current hospitalization
  • Diagnosis of acute kidney injury stage 3 according to KDIGO guidelines
  • RRT initiated no earlier than 3 days before or no later than 7 days after ICU admission

Exclusion criteria

  • Transfer from outside hospital with ongoing RRT
  • RRT exposure of less than 2 days (if CRRT or PD was provided) or less than 2 HD/SLED sessions
  • Kidney failure (ESRD) patients on maintenance dialysis
  • Kidney transplant recipients
  • Previous or new diagnosis of glomerulonephritis

Treatment and study plan

Primary outcomes

  1. In-hospital mortality

    Time frame: From enrollment to hospital discharge or 90 days (whichever occurs first)

    The variable is coded as 1 = deceased and 0 = alive by the time of hospital discharge

Secondary outcomes

  1. ICU mortality

    Time frame: From enrollment to ICU discharge or 90 days (whichever occurs first)

    The variable is coded as 1 = deceased and 0 = alive by the time of ICU discharge

  2. 90-day follow-up mortality

    Time frame: From enrollment to 90-days post-ICU admission follow-up

    The variable is coded as 1 = deceased and 0 = alive by the time of 90-day follow-up

  3. Length of stay in the ICU

    Time frame: From ICU admission to death or ICU discharge (truncated at 90 days)

    Length of stay will be calculated as the total number of full days between admission and discharge from the ICU. A calendar day will be counted toward the total only if the duration of stay on that day is two hours or longer.

  4. Length of stay in the hospital

    Time frame: From hospital admission to death or hospital discharge (truncated at 90 days)

    Length of stay will be calculated as the total number of full days between admission and discharge from the hospital. A calendar day will be counted toward the total only if the duration of stay on that day is two hours or longer.

  5. Renal function recovery at hospital discharge

    Time frame: From enrollment to hospital discharge or 90 days (whichever occurs first)

    Recovery will be defined as improvement in kidney function based on serum creatinine value at hospital discharge compared with baseline serum creatinine.

    Baseline serum creatinine will be defined as either of the following (in order of priority) 1) Average of 3 closest outpatient values 7-365 days before index hospitalization; 2) Lowest value in the inpatient setting 7-365 days before index hospitalization; 3) Lowest value in the first 30 days during index hospitalization (not during or within 48h after RRT discontinuation).

    Patients who have serum creatinine <0.3 mg/dL higher than baseline at hospital discharge will be considered to have recovered renal function.

  6. Renal function recovery at follow-up

    Time frame: From enrollment to 90-days post-ICU admission follow-up

    Recovery will be defined as improvement in kidney function based of serum creatinine value at follow-up compared with baseline serum creatinine.

    Baseline serum creatinine will be defined as either of the following (in order to priority) 1) Average of 3 closest outpatient values 7-365 days before index hospitalization; 2) Lowest value in the inpatient setting 7-365 days before index hospitalization; 3) Lowest value in the first 30 days during index hospitalization (not during or within 48h after RRT discontinuation).

    Patients who have serum creatinine <0.3 mg/dl higher than baseline at follow-up will be considered to have recovered renal function.

  7. RRT dependence at hospital discharge

    Time frame: From RRT initiation to hospital discharge or 90 days (whichever occurs first)

    Patients will be classified as RRT-dependent if they continue to require any form of RRT at discharge. Patients who no longer require RRT will be classified as RRT-independent.

  8. RRT dependence at follow-up

    Time frame: From RRT initiation (day 0) to 90-days post-ICU admission follow-up

    Patients will be classified as RRT-dependent if they continue to require any form of RRT at follow-up assessment. Patients who no longer require RRT will be considered RRT-independent.

  9. Anticoagulation-related complications associated with RRT

    Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)

    These include complications attributable to different types of anticoagulation (systemic unfractionated heparin, systemic low molecular weight heparin, regional citrate anticoagulation, other) used during RRT. Events include hemorrhage, heparin-induced thrombocytopenia (where relevant), citrate excess (where relevant), and citrate deficit (where relevant).

  10. Infectious complications associated with RRT

    Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)

    These include infections associated with RRT. Events include catheter-related bloodstream infections, catheter insertion-site infections, and secondary peritonitis.

  11. RRT-related procedural complications

    Time frame: RRT initiation (day 0) to RRT day 6 or RRT termination (whichever occurs first)

    Procedural or mechanical complications occurring during RRT will be identified from medical records and bedside documentation. These include catheter malfunction (e.g., kinking, disconnection, malposition, migration, catheter tip adherence to vessel wall), circuit interruptions, circuit replacements, RRT downtime (where relevant).

Study contacts

Contact information is provided by the study sponsor or research team.

Javier A Neyra, MD, MSCS

CONTACT

[email protected]

205-975-2021

Patricia J Busta Flores

CONTACT

[email protected]

205-975-2251

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Vantive Health LLC

Registry information

Acronym: LATAM-AKID

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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